Tissue fastening tool

ABSTRACT

A tissue fastening instrument that fastens a first biological tissue and a second biological tissue that is adjacent to the first biological tissue so as to come into close contact, provided with a first tissue fixing portion that consists of an elastic wire that is wound into a coil shape and engaged on the first biological tissue; a second tissue fixing portion that consists of an elastic wire that is wound into a coil shape, is connected to a first end portion of the first tissue fixing portion and engaged on the second biological tissue; and a peripheral spring portion that is connected to a second end portion of the first tissue fixing portion and extends toward the second tissue fixing portion while forming a loop on the outside of the first tissue fixing portion and the second tissue fixing portion, in which the peripheral spring portion has a spring portion that is connected to the second end portion of the first tissue fixing portion and extends toward the second tissue fixing portion, and an end turn portion that is connected to the spring portion and forms, on the outside of the spring portion, a loop that is approximately parallel with a base loop that the first tissue fixing portion and the second tissue fixing portion form; and the base loop, the loop that the spring portion forms, and the loop that the end turn portion forms are disposed so as not to mutually overlap in the diameter direction of the base loop.

The present application is a continuation-in-part of U.S. patent application Ser. No. 12/171,816 “Tissue Fastening Portion” filed Jul. 11, 2008, and U.S. patent application Ser. No. 12/171,817 “Tissue Fastening Instrument, Applicator for Placing the Tool in a Human Body, and Trans-Natural Opening Based Tissue Fastening Method” filed Jul. 11, 2008, and claims priority on the aforementioned two applications.

TECHNICAL FIELD

The present invention relates to a tissue fastening instrument that fixes tissue in a trans-natural opening manner and an applicator that is used when placing this tissue fastening instrument in a body.

BACKGROUND ART

As a method of performing a procedure on an internal organ of a human body and the like, there is known a laparoscope operation that involves percutaneously inserting a treatment tool. This is because since the procedure can be completed with little invasion compared to the case of cutting open the abdominal region, an early recovery can be expected.

The treatment tool that is used in a laparoscope operation has a hard shaft that is percutaneously inserted in a body, with forceps or the like provided at the distal end of the shaft. For example, Japanese Unexamined Patent Application Publication No. 2005-193044 discloses a treatment tool used for the application of joining hollow organs. In this intraluminal anastomosis instrument, a grasping tool that freely opens and closes is attached at the distal end of a shaft, and a fastening instrument is inserted in this shaft. The fastening instrument is capable of being pushed out from the distal end of the shaft by a projection mechanism on the proximal side. The fastening instrument is manufactured from a shape memory alloy that is annealed in a coil shape and inserted in the shaft in a straightened state. When using the fastening instrument, it is inserted into a human body by pushing out with an extrusion mechanism. The fastening instrument reverts to its coil shape by being warmed by body heat. Hollow organs are then joined by the restored fastening instrument.

Another example of supplying a fastening instrument is disclosed in WO 2002/019923 “Surgical Fastener and Delivery System”. Here, the fastening instrument is delivered to the tissue by being pushed out from a needle. For this reason, stops are provided that control the amount of depth that the needle may be inserted into the tissue and the amount of the fastening instrument to be delivered to the tissue. When performing a procedure, a tool that contains the fastening instrument and the needle is placed against the tissue. When the needle has been moved forward to be inserted in the tissue, the position of the fastening instrument is fixed by the stop. Thereafter, the needle is pulled out from the tissue. Since the fastening instrument does not move by the existence of the stops, the distal end portion thereof is left on the inner side of the tissue. When the instrument is removed from the tissue, the remaining portion of the fastening instrument remains on the outer side of the tissue. When the fastening instrument reverts to the coil shape, the tissue is fastened.

DISCLOSURE OF THE INVENTION

The present invention is a tissue fastening instrument that fastens a first biological tissue and a second biological tissue that is adjacent to the first biological tissue so as to come into close contact, provided with a first tissue fixing portion that consists of an elastic wire that is wound into a coil shape and engaged on the first biological tissue; a second tissue fixing portion that consists of an elastic wire that is wound into a coil shape, is connected to a first end portion of the first tissue fixing portion and engaged on the second biological tissue; and a peripheral spring portion that is connected to a second end portion of the first tissue fixing portion and extends toward the second tissue fixing portion while forming a loop on the outside of the first tissue fixing portion and the second tissue fixing portion, in which the peripheral spring portion has a spring portion that is connected to the second end portion of the first tissue fixing portion and extends toward the second tissue fixing portion, and an end turn portion that is connected to the spring portion and forms, on the outside of the spring portion, a loop that is approximately parallel with a base loop that the first tissue fixing portion and the second tissue fixing portion form; and the base loop, the loop that the spring portion forms, and the loop that the end turn portion forms are disposed so as not to mutually overlap in the diameter direction of the base loop.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a cross-sectional view that shows the tissue fastening instrument and applicator in accordance with one embodiment of the present invention.

FIG. 2 is a perspective view of the same tissue fastening instrument.

FIG. 3 is an elevation view and a plan view of the same tissue fastening instrument.

FIG. 4A and FIG. 4B are drawings that show the relationship of the peripheral spring of the same tissue fastening instrument and the force that acts.

FIG. 4C and FIG. 4D are drawings that show the state of the tissue fastening instrument shown in FIG. 4A when placed in tissue.

FIG. 5A and FIG. 5B are drawings that show the relationship of the peripheral spring of the same tissue fastening instrument and the force that acts.

FIG. 5C and FIG. 5D are drawings that show the state of the tissue fastening instrument shown in FIG. 5A when placed in tissue.

FIG. 6 is a drawing that shows the state of the same applicator inserted in an endoscope.

FIG. 7 is a drawing that shows the operation of the same endoscope during use of the same applicator.

FIG. 8A is a drawing that shows the operation during use of the same tissue fastening instrument and the same applicator.

FIG. 8B is a cross-sectional view along line X-X of FIG. 5A.

FIG. 9 to FIG. 11 are drawings that show the operation during use of the same tissue fastening instrument and the same applicator.

FIG. 12A and FIG. 12B are drawings that show the operation when the same tissue fastening instrument is pushed out from the needle tube of the same applicator.

FIG. 13A to FIG. 13D are drawings that show the operation of the same tissue fastening instrument and the same needle tube.

FIG. 14 to FIG. 16 are drawings that show the state of an irregularity occurring during placement of the same tissue fastening instrument.

FIG. 17 to FIG. 21 are drawings that show the operation of the same tissue fastening instrument and the same needle tube in order to suitably place the same tissue fastening instrument.

FIG. 22 is a drawing that shows the state of the end turn portion having run onto the peripheral spring.

FIG. 23 is a drawing that shows the state of the same tissue fastening instrument placed in tissue.

FIG. 24A is a drawing that describes the problem point when placing a tissue fastening instrument with no peripheral spring.

FIG. 24B is a drawing that describes the problem point when placing a tissue fastening instrument in which the shape of the same peripheral spring is not suitable.

FIG. 25A and FIG. 25B are drawings that show the shape in a plan view of the end turn portion.

FIG. 26A and FIG. 26B are drawings that show other aspects of the same end turn portion.

FIG. 27 is a drawing that shows another aspect of the same end turn portion.

FIG. 28 is a drawing that show the state in which the fastening force of the tissue fastening instrument being insufficient.

FIG. 29A and FIG. 29B are drawings that show the joining aspect of the tissue fastening instrument and the stylet in accordance with a modification of the present invention.

FIG. 30A and FIG. 30B are drawings that show end portions of the tissue fastening instrument in accordance with modifications of the present invention.

FIG. 31 is a drawing that shows the end portion of the tissue fastening instrument in accordance a modification of the present embodiment.

FIG. 32A and FIG. 32B are drawings that show another example of a joining aspect of the same tissue fastening instrument and the same stylet.

FIG. 33 is a drawing that shows the end portion of the stylet in accordance with a modification of the present embodiment.

FIG. 34 to FIG. 36 are drawings that show another example of a joining aspect of the same tissue fastening instrument and the same stylet.

FIG. 37 is a drawing that shows another example of a joining aspect of the same tissue fastening instrument and the same stylet.

FIGS. 38A and 38B are drawings that show another example of a joining aspect of the same tissue fastening instrument and the same stylet.

FIG. 39A and FIG. 39B are drawings that show another example of a joining aspect of the same tissue fastening instrument and the same stylet.

FIG. 40A and FIG. 40B are drawings that show another example of a joining aspect of the same tissue fastening instrument and the same stylet.

BEST MODE FOR CARRYING OUT THE INVENTION

Hereinbelow an embodiment in accordance with the present invention shall be described. A tissue fastening device S1 of the present embodiment is a device that integrally fixes a first biological tissue and a second biological tissue, and performs a procedure that brings both tissues into communication. As shown in FIG. 1, it is provided with a tissue fastening instrument 10A and an applicator 50.

Here, the first and the second biological tissue do not necessarily denote different organs. For example, the case is also included in which a region of a certain organ serves as the first biological tissue, and another region of this organ serves as the second biological tissue, when these two regions being fixed. In the present embodiment, a description shall be given using as an example the procedure of the common bile duct serving as the second biological tissue being fixed to the duodenum serving as the first biological tissue, and bringing both organs into communication with one another.

FIG. 2 and FIG. 3 are drawings that show the tissue fastening instrument 10A of the present embodiment. The tissue fastening instrument 10A is equipped with a first tissue fixing portion 11 that is engaged on the duodenum, a second tissue fixing portion 12 that is engaged on the common bile duct which is adjacent to the duodenum, and a peripheral spring portion 13 that is connected to the first tissue fixing portion 11 as shown in FIG. 2.

All of the sections of the tissue fastening instrument 10A, that is, the first tissue fixing portion 11, the second tissue fixing portion 12, and the peripheral spring portion 13, consist of a single high elasticity metal wire (hereinbelow simply referred to as a “metal wire”) 10 that is wound in a coil shape. The first tissue fixing portion 11 and the second tissue fixing portion 12 are formed so as to have the same loop diameter, and with each other's loops being coaxial.

The peripheral spring portion 13 is provided with a spring portion 14 that extends from the end portion of the first tissue fixing portion 11, and an end turn portion 15 that extends from the end portion of the spring portion 14.

The spring portion 14 is extended from the end of the first tissue fixing portion 11 toward the second tissue fixing portion 12 while forming a loop that is larger than the first tissue fixing portion 11 and the second tissue fixing portion 12. The loop that the spring portion 14 forms gradually becomes large as it goes to the side of the second tissue fixing portion 12. Note that that shape is not essential to the present invention, and for example the spring portion 14 may extend toward the second tissue fixing portion 12 while forming a loop of the same diameter.

Since the spring portion 14 extends to the side of the second tissue fixing portion 12, the metal wire 10 that forms the spring portion 14, as shown in FIG. 3, has an angle so as to slope with respect to the axial line of the loop of the first tissue fixing portion 11 and the second tissue fixing portion 12 (hereinbelow called the “base loop”).

The spring portion 14 is preferably formed so as to have an integer winding of 1 or more. An “integer winding of 1 or more” means that, when the tissue fastening instrument 10A is viewed from above as shown in FIG. 4A, an end portion 14A of the spring portion 14 on the side of the first tissue fixing portion 11 and an end portion 14B of the spring portion 14 on the side of the end turn portion 15 are aligned on the same straight line with a center C of a base loop L1 without sandwiching the center C.

When the spring portion 14 is an integer winding of 1 or more, when the tissue fastening instrument 10A is viewed in cross section in the axial direction that passes through the center C, whichever cross section is taken, the spring portion 14 on the outer side in the diameter direction of the base loop L1 is in a state of being uniformly distributed as shown in FIG. 4B. Although FIG. 4B shows the state in which the spring portion 14 is set to one turn, provided it is an integer turn, the state is the same even for two or more turns. Therefore, the force of the spring portion 14 that acts in a direction perpendicular to the axial line of the base loop L1 (direction of a cross-section) becomes equal with respect to the first tissue fixing portion 11 and the second tissue fixing portion 12, and as shown in FIG. 4C and FIG. 4D, even when placed in tissue, the base loop of the first tissue fixing portion 11 and the second tissue fixing portion 12 does not cause axial discrepancy, and the shape is stable.

FIG. 5A to FIG. 5D show an example of the spring portion 14 set to ½ turn as an example of a non-integer turn. In this tissue fastening instrument 110A, end portions 114A and 114B of a peripheral spring 114 are aligned on the same straight line with the center C of the base loop L1, sandwiching the center C.

In this case, as shown in FIG. 5B, depending on how the cross-section in the axial direction passing through the center C is taken, the balance of the quantity of the spring portion 14 that exists on both sides of the first tissue fixing portion 11 and the second tissue fixing portion 12 is upset. When the tissue fastening instrument 110A that has such a spring portion 114 is placed in tissue, as shown in FIG. 5C and FIG. 5D, an axial discrepancy will arise between the base loop L1 and a loop L3 that the end turn portion 15 forms. As a result, a force that is out of balance acts in the cross-sectional direction, which becomes a hindrance to the first tissue fixing portion 11 and the second tissue fixing portion 12 sufficiently exhibiting the tissue fastening force mentioned later, which is not desirable.

The metal wire 10 changes its extension angle at the end portion 14B that corresponds to the connection portion of the spring portion 14 and the end turn portion 15, whereby the end turn portion 15 forms a loop that is perpendicular to the axial line of the base loop L1. Therefore, the loop of the end turn portion 15 is parallel to the base loop L1. As shown in FIG. 2, a through-hole 15B is formed at the end portion 15A of the end turn portion 15, and where the end turn portion 15 has formed a loop of one or more turns, the degree of bending is adjusted so that the end portion 15A touches another portion of the end turn portion 15.

The loop that the end turn portion 15 forms has a larger diameter than the loop that the spring portion 14 forms. Therefore, when the tissue fastening instrument 10A is viewed from the axial direction of the base loop L1 as shown by the plan view in FIG. 3, the base loop L1 is furthest to the inside the second loop L2 that the spring portion 14 forms is to the outside of that, and the third loop L3 that the end turn portion 15 forms is still further to the outside. The base loop L1, the second loop L2, and the third loop L3 are not mutually superimposed in the diameter direction of the base loop L1.

With the tissue fastening instrument 10A extended, one end is inserted in a biological tissue, and one tissue fixing portion, for example the second tissue fixing portion 12, is in turn passed through the intestinal wall of the duodenum and a tubular wall of the common bile duct. The shape of the second tissue fixing portion 12 that has passed through the intestinal wall of the duodenum and the tubular wall of the common bile duct is restored to the original coil shape by removing a restraint on the inner side of a common bile duct, and thus becomes caught on the common bile duct. The shape of the first tissue fixing portion 11 is restored to the original coil shape by removing a restraint on the inner side of the duodenum, and thus becomes caught on the duodenum. Due to the first tissue fixing portion 11 being caught on the duodenum and the second tissue fixing portion 12 being caught on the common bile duct, the intestinal wall of the duodenum and the tubular wall of the common bile duct are fastened and integrally fixed so as to be pressed against each other. At this time, the end turn portion 15 of the peripheral spring portion 13 abuts the intestinal wall of the duodenum around the first tissue fixing portion 11, and the spring portion 14 biases the end turn portion 15 so as to press the intestinal wall against the side of the common bile duct. These points are explained in detail in the explanation of the operation during use of the tissue fastening device S1.

The applicator 50 is an instrument for placing the tissue fastening instrument 10A in a body, and is provided with a main body 51, a needle tube 52, a stylet (fastening instrument pusher) 53, and a sheath 54 as shown in FIG. 1.

The main body 51 is formed in a cylindrical shape and has a needle tube control portion 56, a stylet control portion 57, and a ring member (sheath control portion) 58 a for advancing and retracting the sheath 54 with respect to the main body 51. The needle tube 52, the stylet 53, and the sheath 54 all have flexibility, and are placed in a mutually coaxial shape. These constitute the insertion portion 60, which is pushed into a work channel of an insertion portion of an endoscope, with the insertion portion 60 naturally being longer than the work channel of the endoscope.

The needle tube 52 is used by being accommodated in a cavity with the tissue fastening instrument 10A in an extended state. The distal end surface of the needle tube 52 is formed slanted with respect to the lengthwise direction of the needle tube 52. Thereby, the distal end of the needle tube 52 is finished sharp. The base end of the needle tube 52 is connected to the needle tube control portion 56 provided at the rear of the main body 51.

Note that an electrode is provided at the distal end of the needle tube 52, and so the needle tube 52 may be inserted to pierce the intestinal wall of the duodenum and the tubular wall of the common bile duct while cauterizing biological tissue by passing electricity to the distal end. In this case, the distal end of the needle tube 52 may not be formed with a sharp tip.

The stylet 53 forms a shaft shape, is inserted inside the needle tube 52 in a manner capable of moving, and pushes out the tissue fastening instrument 10A that has been inserted in the needle tube 52 from the distal end of the needle tube 52. A projection 53B is formed at a distal end 53A of the stylet 53, and as shown in FIG. 1, the tissue fastening instrument 10A is accommodated in the needle tube 52 in the state of the through-hole 15B of the end turn portion 15 and the projection 53B being engaged.

For this reason, the tissue fastening instrument 10A becomes integrated with the stylet 53 and capable of moving forward and backward in the needle tube 52, and when the stylet 53 is rotated about the axis line, rotates together with the stylet 53. The gap between the inner cavity of the needle tube 52 and the stylet 53 is set to be smaller than the wire diameter of the metal wire 10 that constitutes the tissue fastening instrument 10A. Therefore, the engagement of the through-hole 15B and the projection 53B does not come apart within the needle tube 52. In addition, in making the gap between inner cavity of the needle tube 52 and the stylet 53 small, the diameter of the stylet 53 may be enlarged, and also the projection length of the projection 53B may be lengthened. Furthermore, instead of making the gap between inner cavity of the needle tube 52 and the stylet 53 small, the maximum diameter of the metal wire 10 may be enlarged, and so by restricting the movable range of the metal wire 10 in the needle tube 52, the aforementioned engagement release may be restricted.

The base end of the stylet 53 is connected to the stylet control portion 57 provided in the inside of the needle tube control portion 56 described below.

The sheath 54 is a tubular member that has flexibility, and the needle tube 52 is inserted in the inner cavity in a movable manner. The distal end face of the sheath 54 is formed flat so as to be orthogonal to the lengthwise direction of the sheath 54.

The needle tube control portion 56 is provided with a cylindrical first shaft 56 a that is inserted in the inner side from the rear end of the main body 51. The outer diameter of the first shaft 56 a is slightly smaller than the inner diameter of the rear portion of the main body 51. Therefore, the first shaft 56 a is capable of sliding on the inner surface of the rear portion of the main body 51. The base end of the needle tube 52 is fixed to the distal end surface of the first shaft 56 a that is inserted in the main body 51 so as to cause the lengthwise direction of the needle tube 52 to coincide with the lengthwise direction of the first shaft 56 a. The needle tube 52, by causing the first shaft 56 a to slide with respect to the main body 51, can change its relative position with the main body 51.

A female screw hole is formed in the diameter direction of the main body 51 at the rear portion of the main body 51, and a external thread 61 is screwed into this female screw hole. The distal end of the external thread 61 projects into the inner cavity of the main body 51. A slot 56 b is formed on the outer surface of the first shaft 56 a along the lengthwise direction of the first shaft 56 a. The distal end of the external thread 61 is loosely fitted in the slot 56 b. Thereby, the slot 56 b regulates the movable range of the first shaft 56 a with respect to the main body 51. By screwing the external thread 61 further into the female screw hole to make the distal end thereof press against the bottom surface of the slot 56 b, it is possible to hold the first shaft 56 a at any position with respect to the main body 51.

The stylet control portion 57 has a cylindrical second shaft 62 that is inserted from the rear end of the first shaft 56 a to the inner side, a lever 63 that is swingably supported by the first shaft 56 a that supports the needle tube 52, a twisted coil spring 64 that biases the lever 63 in a direction away from the main body 51, and a link mechanism 65 that changes the swing movement of the lever 63 to a linear movement along the piercing tool 52 of the stylet 53.

The base end of the stylet 53 is inserted from the distal end of the second shaft 62 to the inside thereof and fixed to the second shaft 62 so as to make the lengthwise direction of the stylet 53 coincide with the lengthwise direction of the second shaft 62. The stylet 53, by causing the second shaft 62 to slide with respect to the first shaft 56 a, can change the relative position with the needle tube 52.

A projection 90 is formed on the periphery of the needle tube 52, and this projection 90 is fitted to a ring slot 91 formed on the circumference of the distal end portion of the needle tube control portion 56. By this, the needle tube 52 is capable of relative rotation with respect to the needle tube control portion 56 while incapable of relative movement in the axial direction. A spirally shaped slot 92 is formed on the outer circumferential surface of the base end side of the needle tube 52 beyond the projection 90.

A pin-shaped projection 93 is provided on the inner circumferential surface of the second shaft 62 that faces the outer circumferential surface of the needle tube 52, and this projection 93 engages with the spirally shaped slot 92 (hereinbelow referred to as “spiral slot 92”). Moreover, a longitudinal groove 94 is formed on the outer circumference of the second shaft 62, and a plate member 72 is attached to the outer side of the second shaft 62 (refer to FIG. 8B). A projection 95 is formed in the inner circumferential portion of the plate member 72, and this projection 95 is fitted in the longitudinal groove 94. Thereby, the second shaft 62 is capable of relative movement in the axial direction in the state of being prevented from rotating with respect to the plate member 72. Due to the mutual correspondence of the ring slot 91 and the projection 90, and the spiral slot 92 and the projection 93, a rotation mechanism 96 is constituted that causes the needle tube 52 to rotate when the second shaft 62 that is prevented from rotating moves forward or backward along the axial direction.

The shape of the spiral slot 92 is set so that when the needle tube 52 rotates with movement of the second shaft 62 in the axial direction, the rotation direction of the needle tube 52 and the coil winding direction of the tissue fastening instrument 10A become reversed. Furthermore, although the stylet 53 pushes out the tissue fastening instrument 10A from the distal end of the needle tube 52 by movement of the second shaft 62 in the axial direction, the shape of the spiral slot 92 is set so that the needle tube 52 completes one rotation each time the tissue fastening instrument 10A is pushed out by only the length of one coil portion from the distal end of the needle tube 52. Therefore, the length of the spiral slot per a rotation of the needle tube differs in the region of the spiral slot 92 that is engaged with the projection 93 when the first tissue fixing portion 11 and the second tissue fixing portion 12 are being pushed out and the region of the spiral slot 92 that is engaged with the projection 93 when the peripheral spring portion 13 is being pushed out.

In addition, although the present embodiment provides the spiral slot 92 in the outer circumference of the needle tube 52 and the projection 93 in the inner circumference of the second shaft 62, it is not limited thereto. Instead, a projection may be provided on the outer circumference of the needle tube 52, the spiral slot may be provided on the inner circumference of the second shaft 62, the spiral shape may be a convexity instead of a slot, and the rotation mechanism may be constituted using a projection or the like that is capable of engagement therewith.

The link mechanism 65 is provided with a base member 66, a bracket 68, a bar 70, a plate member 72, and a compression coil spring 74. The base member 66 is fixed to the outside surface of the first shaft 56 a. The bracket 68 is pivotally supported by the base member 66. The lever 63 is fixed to the lower end of the bracket 68. The bar 70 is pivotally supported by the bracket 68 at one end, and is pivotally supported by the base portion material 66 at the other end. A pin 71 provided at the other end of the bar 70 is fitted in a long hole 66 a formed in the base member 66 along the sliding direction of the second shaft 62 in a manner providing play.

A hole 73 with a diameter that is larger than the outer diameter of the second shaft 62 is formed in the plate member 72, and the second shaft 62 that is inserted in the first shaft 56 a is passed through this hole 73. The difference of the outer diameter of the second shaft 62 and the inner diameter of a hole 73 is extremely small, and by leaning the plate member 72 to move in the lengthwise direction of the second shaft 62, that is, the insertion direction of the second shaft 62 in the first shaft 56 a, the inner surface of the hole 73 interferes with the outer surface of the second shaft 62 to cause friction, whereby a force that is added to the plate member 72 acts on the second shaft 62.

The compression coil spring 74 is disposed inside of the first shaft 56 a, and biases the plate member 72 in the opposite direction of the insertion direction of the second shaft 62 in the first shaft 56 a.

When the lever 63 is moved in the direction of approaching the main body 51, the bar 70 is pulled towards the front of the main body 51 via the bracket 68, and the other end of the bar 70 moves along the long hole 66 a. The plate member 72 is pushed by the other end of the bar 70 and moves in the insertion direction of the second shaft 62 in the first shaft 56 a, resisting the compression coil spring 74. Since friction is produced between the second shaft 62 and the plate member 72 as a result of the latter tilting slightly, the force that is added to the plate member 72 acts on the second shaft 62, and the second shaft 62 is thrust into the first shaft 56 a.

When the lever 63 is released, the twisted coil spring 64 causes the lever 63 to separate from the main body 51, and the compression coil spring 74 pushes only the plate member 72 back to its initial position without causing friction with the second shaft 62.

Since the amount of movement of the other end of the bar 70 per operation of the lever 63 is always constant, the insertion length of the second shaft 62 into the first shaft 56 a per operation of a lever 63 is also always constant. Therefore, it is possible to control the insertion length of the second shaft 62 into the first shaft 56 a, that is, the insertion length of the stylet 53 into the needle tube 52 according to the number of times of operation of the lever 63. This means that it is possible to control the length of the tissue fastening instrument 10A pushed out from the distal end of the needle tube 52 according to the number of times of operation of the lever 63.

When the tissue fastening instrument 10A forms a coil shape that has a loop outside of the needle tube 52 as in the present embodiment, the insertion length of the stylet 53 per operation of the lever 63 is preferably about n times of the loop of the tissue fastening instrument 10A or about 1/n times (n being a natural number).

For example, if the insertion length of the stylet 53 per operation of the lever 63 is almost equal to the circumference of the tissue fastening instrument 10A, whenever the lever 63 is operated once, the tissue fastening instrument 10A will be pushed out from the distal end of the needle tube 52 by an amount corresponding to one turn. Moreover, when the second tissue fixing portion 12 is a two-turn portion of the tissue fastening instrument 10A, by operating the lever 63 two times, it is possible to push out only the second tissue fixing portion 12 from the distal end of the needle tube 52.

Moreover, if the insertion length of the stylet 53 per operation of the lever 63 is almost equal to half of the circumference of the tissue fastening instrument 10A, whenever the lever 63 is operated once, the tissue fastening instrument 10A will be pushed out from the distal end of the needle tube 52 by an amount corresponding to half a turn. Furthermore, when the second tissue fixing portion 12 is a two-turn portion of the tissue fastening instrument 10A, by operating the lever 63 four times, it is possible to push out only the second tissue fixing portion 12 from the distal end of the needle tube 52.

Moreover, regarding the spring portion 14 and the end turn portion 15 of the peripheral spring portion 13, by setting the length thereof to an integral multiple of the insertion length of the stylet 53 per single operation of the lever 63, it is possible to push out only the spring portion 14 or the end turn portion 15 from the needle tube 52.

A mouth ring 80 is inserted at the distal end of the main body 51. An inner screw 80A is formed in the mouth ring 80, and by screwing the inner screw 80A into a cap of an endoscope, it is possible to fix the applicator 50 to the endoscope. On the outer surface of the mouth ring 80, a groove 81 is formed along the circumferential direction. A female screw hole that extends in the diameter direction is formed in the main body 51, and a external thread 82 is screwed into this female screw hole. The distal end of the external thread 82 projects to the inside of the main body 51. The distal end of the external thread 82 loosely fits into the groove 81 of the mouth ring 80. Thereby, it is possible to freely rotate the entire applicator 50 with respect to the mouth ring 80 that is fixed to the endoscope. By further screwing the external thread 82 into the female screw hole to make the distal end thereof press against the bottom surface of the groove 81, it is possible to position and hold the main body 51 at any position in the circumferential direction with respect to the mouth ring 80.

FIG. 6 shows a linear scanning-type ultrasonic endoscope (hereinbelow simply referred to as an “endoscope”) 2 as an example of an endoscope that is used together with the tissue fastening device S1. The endoscope 2 is provided with a flexible insertion portion 4 that extends from the control portion 3 that is used outside a body.

A knob 3A and various buttons 3B that cause the distal end portion of the insertion portion 4 to curve are provided in the control portion 3. A cover 5 is attached to the distal end of the insertion portion 4. An ultrasonic device 6 is attached to this cover 5.

The ultrasonic device 6 bulges out on a plane that includes the axial line of the insertion portion 4, and a plurality of ultrasonic transducers are arranged along the circular periphery. Moreover, an elevator base 7 is provided so as to feed the distal end portion of the applicator 50 to the side. By operating the elevator base 7 proximally, it is possible to adjust the direction of the insertion portion 60 of the applicator 50 that is fed out from the distal end of the insertion portion 4. Note that the endoscope 2 may also be provided with another probe-type ultrasonic endoscope. Also, it is possible to use an endoscope that does not have the ultrasonic device 6. In this case, an ultrasonic device that is used outside of the body, an X-ray device, a magnetic resonance imaging device, or a computerized tomography device are used in combination.

Next, a procedure shall be explained of placing the tissue fastening instrument 10A in an abdominal cavity using the tissue fastening device S1 constituted as mentioned above, integrally fixing the duodenum and the common bile duct, and forming a hole that brings both into communication. This kind of procedure, as shown for example in FIG. 7, is carried out in the case of the discharge of bile being prevented by blockage of the duodenal papilla Dp by a tumor Tr, causing jaundice in which the bile is absorbed into blood. By this procedure, it is possible to directly discharge the bile from the common bile duct Cb to the duodenum Dd.

First, the insertion portion 4 of the endoscope 2 is inserted from a patient's mouth. The endoscope 2 is inserted in the duodenum Dd which is the upper part of the gastrointestinal tract. The state of the outer side of the duodenum Dd is investigated with the ultrasonic endoscope 6, and a location suitable for the procedure near the common bile duct Cb is searched for on the stomach St side from the duodenal papilla Dp.

The operator in advance retracts the needle tube 52 with respect to the main body 51 by operating the first shaft 56 a of the applicator 50, and retracts the stylet 53 with respect to the main body 51 by operating the second shaft 62, as shown in FIG. 5A. Furthermore, by operating the ring member 58 a, the sheath 54 is retracted with respect to the main body 51, In this state, the distal end of the needle tube 52 in which the tissue fastening instrument 10A has been inserted is drawn to the inside of the sheath 54.

The operator inserts the insertion portion 60 of the applicator 50 in the work channel of the endoscope 2 and makes it move forward, and engages the mouth ring 80 with a forceps plug 8 of the endoscope to fix the applicator 50 to the endoscope 2. Thereby, the distal end of the insertion portion 60 is protruded from the distal end of the insertion portion 4 of the endoscope 2. Then, the direction of the protruded insertion portion 60 is adjusted by the elevator base 7.

The common bile duct Cb beyond the duodenum Dd is scanned using the ultrasonic device 6 provided in the endoscope 2, and the location to insert the needle tube 52 in the common bile duct Cb is determined. As shown in FIG. 9, the external thread 61 is loosened, the first shaft 56 a is pushed into the main body 51, and the distal end of the needle tube 52 is made to project from the distal end of the sheath 54. Thereby, the sharp distal end of the needle tube 52 pierces through the intestinal wall Wd of the duodenum Dd from the inside to the outside, and successively pierces through the wall Wc of the common bile duct Cb from the outside to the inside. The operator then tightens the external thread 61 to fix the first shaft 56 a to the main body 51.

The operator, as shown in FIG. 10, operates the lever 63 to push the second shaft 62 into the first shaft 56 a by a predetermined amount. For example, the lever 63 may be operated a definite number of times. Thereby, the stylet 53 changes the relative position with the needle tube 52, and the second tissue fixing portion 12 of the tissue fastening instrument 10A is pushed out from the distal end of the needle tube 52. At this time, along with the advance of the second shaft 62, the projection 93 provided in the second shaft 62 moves along the spiral slot 92 of the needle tube 52. Meanwhile, rotation of the second shaft 62 is restricted by the projection 95 of the plate member 72 being engaged in the longitudinal groove 94 formed in the outer circumference. As a result, the needle tube 52 rotates with the advance of the second shaft 62. Since the tissue fastening instrument 10A and the stylet 53 are united at this time by the projection 53B being engaged in the through-hole 15B of the end turn portion 15, the advance and retreat as well as rotation of the stylet are suitably transmitted to the tissue fastening instrument 10A.

As the rotation direction of the needle tube 52 when viewed from the base end side of the main body 51 becomes the opposite to the coil winding direction of the tissue fastening instrument 10A to be pushed out from the distal end of the needle tube 52, the second tissue fixing portion 12 to be pushed out from the needle tube 52 promptly reverts to the coil shape prior to being accommodated in the needle tube 52 without twisting (this is explained in detail below), and catches onto and holds the inner side of the wall Wc of the common bile duct Cb.

The external thread 61 is loosened, the first shaft 56 a is pulled out a little from the main body 51, and the projection length from the distal end of the sheath 54 of the needle tube 52 is shortened. Then, the external thread 61 is tightened to again fix the first shaft 56 a to the main body 51. Thereby the distal end of the needle tube 52 is spaced a little away from the internal surface of the intestinal wall Wd of the duodenum Dd.

As shown in FIG. 11, the lever 63 is again operated to push the second shaft 62 into the first shaft 56 by a predetermined amount. For example, the lever 63 may be operated a definite number of times. Thereby, the stylet 53 changes the relative position with the needle tube 52, and the first tissue fixing portion 11 of the tissue fastening instrument 10A is pushed out from the distal end of the needle tube 52. At this time, similarly to during the pushing out of the second tissue fixing portion 12, the needle tube 52 rotates in the opposite direction to the coil winding direction of the tissue fastening instrument 10A. As a result, when the first tissue fixing portion 11 is pushed out from the needle tube 52, it promptly reverts to the initial coil shape without twisting (this is explained in detail below), and catches onto and holds the inner side of the intestinal wall Wd of the duodenum Pd.

Below, the action of the tissue fastening instrument 10A pushed out from the distal end of the needle tube 52 in the procedure mentioned above is explained in detail.

First, the tissue fastening instrument 10A is pushed out from the distal end of the needle tube 52 that has penetrated the intestinal wall Wd of the duodenum Dd and the wall Wc of the common bile duct Cb, so that only the second tissue fixing portion 12 is projected. The second tissue fixing portion 12, in the process of being pushed out from the distal end of the needle tube 52, successively reverts to its original coil shape and catches onto and holds the wall Wc of the common bile duct Cb.

The tissue fastening instrument 10A that is loaded in the extended state in the needle tube 52 always tries to return to its original coil shape outside of the needle tube 52 due to the elastic force. As a result, when pushed out from the distal end of the needle tube 52, as shown in FIG. 12A and FIG. 12B, it is pushed out at an opening portion 100 that is closest to the root side at the distal end of the needle tube 52 while heading to the surface that becomes the inside of the loop. Here, in the case of the distal end of the needle tube 52 having a sloped opening 52 a that obliquely slopes like a hypodermic needle, the tissue fastening instrument 10A is pushed out from the most root side of the sloped opening 52 a, and so tries to return to the original shape while existing on a plane that is approximately perpendicular with respect to a sloped opening plane 52 aa.

Therefore, if the needle tube 52 is rotated simultaneously while pushing out the tissue fastening instrument 10A from the sloped opening 52 a of the needle tube 52, the tissue fastening instrument 10A will rotate united with the needle tube 52.

In the event of pushing out the tissue fastening instrument 10A from the needle tube 52, when the tissue fastening instrument 10A cannot make contact with the surrounding common bile duct wall Wc, the tissue fastening instrument 10A correctly returns to its original shape. However, when the tissue fastening instrument 10A can make contact with the surrounding common bile duct wall Wc and the like, the tissue fastening instrument 10A may be unable to return to the original shape.

This phenomenon shall be described using as an example the case where the tissue fastening instrument 10A is a clockwise-wound (Z winding) coils If the tissue fastening instrument 10A is further pushed out from the needle tube 52 from the state of FIGS. 12A and 12B, ordinarily it returns to the original clockwise-wound coil as shown in FIG. 13A. However, in the case of the tissue fastening instrument 10A making contact with the common bile duct wall Wc as shown in FIG. 13B, there is a possibility of the tissue fastening instrument 10A being pushed by the common bile duct wall Wc and becoming a counterclockwise-wound coil (S winding) coil that is the opposite from the original.

In order to prevent this, as shown in FIG. 13C, the tissue fastening instrument 10A should be pushed out from the needle tube 52 while causing it to rotate integrally with the needle tube 52 so as to rotate in the opposite direction from the winding direction of the tissue fastening instrument 10A as shown in FIG. 13C, that is, if the tissue fastening instrument 10A is a clockwise-wound coil, to rotate to the left if viewing the needle tube 52 from the base end. By doing so, the tissue fastening instrument 10A will rotate to the left with the needle tube 52, and push the common bile duct wall Wc. Thereby, the tissue fastening instrument 10A returns to the original clockwise winding coil.

In the applicator 50 of the present embodiment, the shape of the spiral slot 92 is set so that the rotation direction of the needle tube 52 may rotate in a counterclockwise manner toward the distal end side, which is the opposite from the winding direction of the tissue fastening instrument 10A. Accordingly, when letting out the tissue fastening instrument 10A, the needle tube 52 and the stylet 53 are rotated in the counterclockwise direction. Furthermore, since the tissue fastening instrument 10A and the stylet 53 are engaged, rotation of the stylet 53 is favorably transmitted to the tissue fastening instrument 10A, whereby the tissue fastening instrument 10A is let out from the needle tube 52 while being reliably rotated. By these actions, as shown in FIG. 13), the tissue fastening instrument 10A that is pushed out to the outside of the needle tube 52 favorably reverts to the original clockwise wound loop shape, and so tangling and a reduction in tissue fastening strength due to changes in the winding direction are prevented.

After the second tissue fixing portion 12 of the tissue fastening instrument 10A is pushed out from the needle tube 52 in the common bile duct Cd, the first tissue fixing portion 11 is pushed out from the distal end of the needle tube 52 that has been pulled out from the intestinal wall Wd of the duodenum Dd and the wall Wc of the common bile duct Cb. At this time as well, since the needle tube 52 is rotated simultaneously while pushing out the tissue fastening instrument 10A from the sloped opening 52 a of the needle tube 52, the portion of the base loop of the tissue fastening instrument 10A is smoothly placed.

After the tissue fastening instrument 10A is latched onto the second biological tissue, FIG. 14 to FIG. 16 are drawings that explain the problem when being latched onto the first biological tissue. As shown in these drawings, after the tissue fastening instrument 10A is latched onto, for example, the wall Wc of the common bile duct Cd that is the second biological tissue, when being latched onto for example the intestinal wall Wd of duodenum Dd that is the first biological tissue, due to the force of the tissue fastening instrument 10A trying to return to its original coil shape, a twisted portion 131 occurs as shown in FIG. 15, and finally as shown in FIG. 16, the tissue fastening instrument 10A may be placed in a tangled state starting from the twisted portion 131.

In the tissue fastening instrument 10A and the applicator 50 of present embodiment, the above tangling is suitably prevented. This is explained in detail below.

Since the motion of the tissue fastening instrument 10A returning to the coil shape on the intestinal wall Wd of the duodenum Dd at the time of placing is also a rotating motion above the intestinal wall Wd as shown in FIG. 17 to FIG. 21, if the motion of this tissue fastening instrument 10A and the rotation of the needle tube 52 are synchronized, placing of the tissue fastening instrument 10A goes smoothly.

Specifically, in the case of the tissue fastening instrument 10A being wound clockwise, the metal wire 10 that constitutes the tissue fastening instrument 10A, when viewed from the base end side, extends in the counterclockwise direction toward the base end side. Therefore, as shown in FIG. 17 from FIG. 21, as a result of the needle tube 52 rotating counterclockwise when viewed from the base end side, the rear end side of the tissue fastening instrument 10A is smoothly let out to the outside of the needle tube 52, and reverts to the clockwise loop shape as shown in FIG. 21 without causing twisting or tangling. Furthermore, since the rotating mechanism 96 is set so that the needle tube 52 rotates approximately one revolution when the tissue fastening instrument 10A is pushed out by a length equivalent to approximately one turn of a loop from the distal end of the needle tube 52, when the needle tube 52 completes one revolution, one turn of the loop of the tissue fastening instrument 10A is reverted outside the needle tube 52. As a result, the rotation operation of the needle tube 52 and the placement operation of the tissue fastening instrument 10A are synchronized at a high level, and the placement becomes easier.

After placement of the first tissue fixing portion 11 is completed, the spring portion 14 and the end turn portion 15 are let out to the outside of the needle tube 52 continuously. Also at this time, since the needle tube 52 is rotated in the counterclockwise direction as mentioned above when viewed from the base end, each part of the peripheral spring portion 13 is smoothly let out and reverts to the loop shape of prior to being accommodated in the needle tube 52. Since the loop diameter of the end turn portion 15 is larger than the loop diameter of the spring portion 14, as shown in FIG. 22, the end turn portion 15 runs onto the spring portion 14, and there is no reduction in the amount of pressing-down force of the intestinal wall Wd described below.

When the entire tissue fastening instrument 10A is pushed out to the outside of the needle tube 52, the engagement of the through-hole 15B in the end portion 15A of the end turn portion 15 and the projection 53B of the stylet 53 will naturally be released, and the tissue fastening instrument 10A will be separated from the stylet 53. In this way as shown in FIG. 11 and FIG. 23, placement of the tissue fastening instrument 10A is completed. By placement of the tissue fastening instrument 10A, the first tissue fixing portion 11 and the second tissue fixing portion 12 fasten the intestinal wall Wd of the duodenum and the wall Wc of the common bile duct so as to be firmly attached, and the peripheral spring portion 13 presses the intestinal wall Wd to the side of the duct wall Wc.

When the tissue fastening instrument 10A is not provided with the peripheral spring portion 13, as shown in FIG. 24A, when punctured by the needle tube 52, a gap Ga is formed between a hole We that is formed in the wall Wc of the common bile duct and the metal wire 10 that is arranged to pass through the hole We, and a phenomenon occurs in which a bodily fluid such as bile or the like flows out through this gap Ga and leaks into the abdominal cavity through a gap Gb between the intestinal wall Wd of the duodenum and the wall We of the common bile duct. In the case of the bodily fluid being bile, there is the possibility of causing bile peritonitis. Also, even if the peripheral spring portion is present, when the end turn portion 15 that is firmly attached to the intestinal wall Wd does not form a closed loop, as shown in FIG. 24B, a gap arises in the intestinal wall Wd being pressed, and so there is a possibility of a leakage of a bodily fluid similarly occurring.

In the tissue fastening instrument 10A of the present embodiment, since the end portion 15A of the end turn portion 15 is in contact with a portion of the end turn portion 15 that has completed at least one rotation, as shown in FIG. 25A, a loop closed by the end turn portion 15 is formed. As a result, since the intestinal wall Wd on the outside of the base loop L1 is pressed in the shape of a closed ring, even if the tissue fastening instrument 10A is placed without generating the gap Gb, and bodily fluid such as bile does leak out through the gap Ga, this bodily fluid does not leak from the gap between the intestinal wall Wd of the duodenum and the wall Wc of the common bile duct into the abdominal cavity.

Provided the end turn portion 15 forms a closed loop, there is no particular restriction on the aspect of connection between the end portion 15A and another section of the end turn portion 15. Therefore, as shown in FIG. 26A, the end portion 15A may tuck under another portion of the end turn portion 15, and as shown in FIG. 26B, the end portion 15A may run onto the top of another portion of the end turn portion 15. Furthermore, as shown in FIG. 27, the end portion 14B of the peripheral spring that serves as a boundary point of the spring portion 14 and the end turn portion 15 may be located inside the third loop L3 that the end turn portion 15 forms. Also, when the end turn portion 15 forms a loop of one or more turns, the section that extends from after the first turn may be completely superimposed on another end turn portion in the diameter direction of the third loop L3.

Note that the end portion 15A does not need to touch the end turn portion 15 with certainty, and provided the gap between the end portion 15A and another portion of the end turn portion 15 is small enough as shown in FIG. 25B, as the entire end turn portion 15, it can press down the intestinal wall Wd without a gap. Even in such a case, the end turn portion 15 can be said to substantially form the closed loop, and so there is no problem. Furthermore, the shape of the peripheral spring portion 13 may be set so as to form an essentially closed loop when the tissue fastening instrument 10A has been placed in tissue and the end turn portion 15 abuts the first biological tissue, with the end portion 15A and another portion of the turn portion 15 not making contact when the tissue fastening instrument 10A has not been placed.

After the tissue fastening instrument 10A has been placed, the operator recovers the needle tube 52 of the applicator 50 into the sheath 54, removes the applicator 50 and the endoscope 2 to outside of the body, and ends the procedure.

The intestinal wall Wd of the duodenum and the wall Wc of the common bile duct that are located in the base loop L1 are bound tight by the first tissue fixing portion 11 and the second tissue fixing portion 12, whereby the flow of blood is blocked, and in due time pressure necrosis is caused, Simultaneously, the intestinal wall Wd and the duct wall We carry out adhesion bonding around the base loop L1.

The necrosed tissue and the tissue fastening instrument 10A drop out of the placement position. Since the first tissue fixing portion 11 and the second tissue fixing portion 12 are always biased by the peripheral spring portion 13 to the side of the cavity of the duodenum, when the tissue fastening instrument 10A drops from the other tissue, it always drops to the side of the cavity in the duodenum, and the tissue fastening instrument 10A is quickly excreted out of the body through the small intestine and the large intestine. Since the end portion 15A of the end turn portion 15 which was engaged with the stylet 53 extends to another portion of the end turn portion 15, there is no damage to other tissue in the body during the excretion process.

Although the peripheral spring portion 13 presses the intestinal wall Wd of the duodenum onto the duct wall We side of the common bile duct, the reaction force at this time acts as a force that pulls the first tissue fixing portion 11 away from the intestinal wall Wd. Therefore, when the initial tension of the first tissue fixing portion 11 is less than the biasing force of the peripheral spring portion 13, as shown in FIG. 28, the fastening force between the first tissue fixing portion 11 and the second tissue fixing portion 12 weakens, and gaps form between the metal wire 10 of the first tissue fixing portion 11.

In this way, if the force that binds the intestinal wall Wd and the duct wall Wc becomes weak, the flow of the blood between the intestinal wall Wd and the duct wall Wc cannot be sufficiently blocked. Moreover if gaps appear between the metal wire 10 that constitutes the first tissue fixing portion 11, flow of blood will occur between the tissue in the base loop L1 and the tissue outside thereof. For that reason, the tissue in the base loop L1 will not necrose. Accordingly, the tissue fastening instrument 10A will not drop and so it will subsequently also not be possible to form a fistula.

In the tissue fastening instrument 10A of the present embodiment, the initial tension of the first tissue fixing portion 11 is set to such an extent that, in the event of the tissue fastening instrument 10A of present embodiment being placed in the body, in the case of receiving the reaction force when the distal end of the peripheral spring portion 13 has pressed down the intestinal wall Wd, the first tissue fixing portion 11 is not pulled away from the intestinal wall Wd as shown in FIG. 23, and gaps do not form between the metal wire 10. As a result, at the time of placement, it is possible to maintain the joined state without gaps appearing between the metal wire 10 of the first tissue fixing portion 11. Therefore, the flow of blood to the tissue in the base loop L1 is favorably blocked, and the tissue concerned reliably necroses. Thereafter, the tissue fastening instrument 10A and the necrosed tissue fall out, and a fistula that connects the intestinal wall Wd of the duodenum and the duct wall Wc of the common bile duct is formed.

According to the tissue fastening instrument 10A of the present embodiment, the first tissue fixing portion 11 and the second tissue fixing portion 12 favorably fasten the first biological tissue and the second biological tissue, and necrose a portion of both while bonding another portion of both, and so it is possible to readily form a fistula that brings the first biological tissue and the second biological tissue into communication.

Moreover, in the peripheral spring portion 13, the second loop L2 that the spring portion 14 forms is larger than the base loop L1 that the first tissue fixing portion 11 and the second tissue fixing portion 12 form, and the third loop L3 that the end turn portion 15 forms is set to be larger than the second loop L2, and these loops are set so as not to mutually overlap in the diameter direction of the base loop L1.

Therefore, it is possible to safely use in a manner such that each section reliably exhibits the respective predetermined fastening force or biasing force without twisting or tangling of the metal wires in the loops occurring.

Furthermore, since the end portion 15A of the end turn portion 15 extends toward another part of the end turn portion 15, the end turn portion 15 forms a closed loop, and in addition to suitably preventing leakage of a bodily fluid as mentioned above, the end portion 15A is not exposed, and injury to other tissue is hindered in the process of the tissue fastening instrument 10A being discharged to outside of the body.

Moreover, according to the applicator 50 of the present embodiment, in the state of the tissue fastening instrument 10A being accommodated in the needle tube 52, since the tissue fastening instrument 10A and the stylet 53 are engaged, forward/backward movement and rotation of the stylet 53 are suitably transmitted to the tissue fastening instrument 10A as mentioned above.

When the stylet 53 and the tissue fastening instrument 10A are not engaged, due to the restoring force of the tissue fastening instrument 10A trying to return to its original form outside the needle tube 52, it may deviate to outside of the needle tube 52 to a region not intended, and so the tissue fastening instrument 10A may not return to its shape of before accommodation. If the stylet 53 and the tissue fastening instrument 10A are connected, such unintended deviation of the tissue fastening instrument 10A is suppressed, and the tissue fastening instrument 10A reliably reverts to the shape of prior to being accommodated and is placed.

Moreover, when the tissue fastening instrument 10A and the stylet 53 can be engaged, by retracting the stylet 53 in the needle tube 52 while causing it to rotate, it is possible to readily accommodate the tissue fastening instrument 10A in the needle tube 52.

Furthermore, as for the tissue fastening instrument 10A and the stylet 53, since the engagement is naturally released outside of the needle tube 52, it is possible to carry out placement of the tissue fastening instrument 10A without requiring the operator to perform a special operation for releasing the engagement.

The joining aspect of the tissue fastening instrument 10A and the stylet 53 is not limited to that mentioned above, and various aspects may be adopted. For example, as shown by the modification in FIGS. 29A and 29B, hooks 21 that are mutually engagable are provided at the distal end 53A of the stylet 53 and the end portion 15A of the end turn portion 15 of the tissue fastening instrument 10A, and both may be detachably connected in the needle tube 52. In providing the hooks 21, grinding or the like may be performed on the distal end 53A and the end portion 15A, or a member is shaped like the hook 21 may be attached to the distal end 53A and the end portion 15A by caulking or welding and the like. Moreover, in the above-mentioned modification, although the example was described of the distal end 53A and the end portion 15A having the identical hooks 21, as long as engagement/disengagement is possible, hooks of different shapes may be respectively attached. However, if identical hooks are used, by reducing the number of parts, it is possible to raise manufacturing efficiency.

Moreover, when providing a through-hole in the end portion 15A, in the manner of the modification shown in FIG. 30A, the end portion 15A may be lengthened, and a through-hole 22 may be formed, and in the manner of the modification shown in FIG. 30B, a step portion 23 may be formed by grinding or the like, and a through-hole 23A may be formed in the step portion 23. Furthermore, in the manner of the modification shown in FIG. 31, a bottomed concavity 24 may be provided in place of a through-hole.

Moreover, the distal end of a projection that is provided on the stylet 53 may be formed sloping to the base end side in the manner of a projection 25 shown in FIG. 32A. By doing so, when moving the stylet 53 in the direction of arrow A1 shown in FIG. 32B, since the engagement with the tissue fastening instrument 10A is hindered from separating, it is easy to accommodate the tissue fastening instrument 10A in the needle tube 52 at the time of manufacture etc. When moving the stylet 53 in the direction of arrow A2, the engagement of both is easily separated, and smooth operation during placement is possible. In this case as sell, by suitably setting the dimensions of the stylet 53 and the tissue fastening instrument 10A with respect to the needle tube 52, it is possible to suitably prevent the engagement from coming apart in the needle tube 52 by reducing the movable width in the cross-sectional direction of the stylet 53 and the tissue fastening instrument 10A in the needle tube 52. The above-mentioned effect can be similarly obtained even in the case of forming at the base end side a projection 26 so as to have a slope 26A that forms an acute angle with the axial line of the stylet 53 as in the modification shown in FIG. 33.

Furthermore, in the manner of the modification shown in FIG. 34 and FIG. 35 (a sectional view along line A-A of FIG. 34), an engaging portion 27 and an engaged portion 28 may be formed so as to respectively have restriction portions 27A and 28A that enable engagement/disengagement of the tissue fastening instrument 10A and the stylet 53 and restrict their relative movement in the width direction. By doing so, as shown in FIG. 36, since movement of the tissue fastening instrument 10A and the stylet 53 in the width direction (the direction shown by the arrows in FIG. 36) is restricted, it is easy to accommodate the tissue fastening instrument 10A in the needle tube 52 while engaged with the stylet 53 during manufacturing. The shapes of the restriction portions are not particularly limited provided they are capable of restricting movement of the tissue fastening instrument 10A and the stylet 53 in the width direction. For example, an engaging portion 29 and an engaged portion 30 that have as restriction portions a convex portion 29A and a concave portion 30A, respectively, as shown in FIG. 37 may be provided in the tissue fastening instrument 10A and the stylet 53, respectively.

Furthermore, as shown in FIG. 38A, a region of a fixed length on the distal end side of at least a stylet 153 may be formed in a hollow shape that has an inner cavity, and a through-hole 31 may be formed on the outer periphery surface, and by causing the end portion 15A of the end turn portion 15 of the tissue fastening instrument 10A to enter the inner cavity and project from the through-hole 31, the stylet 153 and the tissue fastening instrument 10A may be engaged. However, in this case, when an opening end face 153A at the distal end of the stylet 153 is shaped so as to be perpendicular to the axial line of the stylet 153, as shown in FIG. 38B, the peripheral surface of the end portion 15A may catch on the inner surface of the stylet 153, and the engagement may be hindered from release outside of the needle tube 52. For this reason, as shown in FIG. 39A, it is good to set the shape of an opening end face 153B so that the length of the stylet 153 is shortest at the position facing the through-hole 31, sandwiching the axial line of the stylet 153. When doing so, as shown in FIG. 39B, during the release of the engagement, it is preferred to hinder the peripheral surface of the end portion 15A from abutting the inner surface of the stylet 153 in order to facilitate release of the engagement outside of the needle tube 52.

Note that in the modification shown from FIG. 38A to FIG. 39B, the end portion 15A of the end turn portion 15 of the tissue fastening instrument 10A may be bent so as to facilitate engagement in the through-hole 31.

Also, instead of providing a projection on one of the tissue fastening instrument 10A or the stylet 53, the end portion of one may be bent and engaged in a through-hole 32A or 32B that is provided in the end portion of the other and has a larger diameter than the wire diameter of the other shown in FIG. 40A and FIG. 40B. In this case, in order to enable entry of the end portion of one, a through-hole with a diameter that is comparatively larger is required, so it is good to provide the though-hole 22 or the like by the method shown in FIG. 30A in the tissue fastening instrument 10A or the stylet 53.

While preferred embodiments of the invention have been described and illustrated above, it should be understood that these are exemplary of the invention and are not to be considered as limiting. Additions, omissions, substitutions, and other modifications can be made without departing from the spirit or scope of the present invention. Accordingly, the invention is not to be considered as being limited by the foregoing description, and is only limited by the scope of the appended claims. 

1. A tissue fastening instrument that fastens a first biological tissue and a second biological tissue that is adjacent to the first biological tissue so as to come into close contact, comprising: a first tissue fixing portion that consists of an elastic wire that is wound into a coil shape and engaged on the first biological tissue; a second tissue fixing portion that consists of an elastic wire that is wound into a coil shape, is connected to a first end portion of the first tissue fixing portion and engaged on the second biological tissue; and a peripheral spring portion that is connected to a second end portion of the first tissue fixing portion and extends toward the second tissue fixing portion while forming a loop on the outside of the first tissue fixing portion and the second tissue fixing portion, wherein the peripheral spring portion has: a spring portion that is connected to the second end portion of the first tissue fixing portion and extends toward the second tissue fixing portion; and an end turn portion that is connected to the spring portion and forms, on the outside of the spring portion, a loop that is approximately parallel with a base loop that the first tissue fixing portion and the second tissue fixing portion form; and the base loop, the loop that the spring portion forms, and the loop that the end turn portion forms are disposed so as not to mutually overlap in the diameter direction of the base loop.
 2. The tissue fastening instrument according to claim 1, wherein the loop that the peripheral spring forms is set to have an integer winding of 1 or more.
 3. The tissue fastening instrument according to claim 1, wherein the end turn portion forms a loop of one or more turns.
 4. The tissue fastening instrument according to claim 3, wherein the end turn portion forms an essentially closed loop when abutting at least the first biological tissue. 